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IBC's Biopharmaceutical Development & Production Week will feature FDA and EMEA Feedback from QbD Case Study on Wednesday, March 3, 2010. Results from the CMC Biotech Working Group will be presneted presented by Eli Lilly and Company and Pfizer Inc.

Upstream Process Development Using a QbD Approach - Results from the CMC Biotech Working Group Case Study
The QbD approach for upstream development of a monoclonal antibody as described in the recent industry consortium case study (CMC BWG) will be presented. The case study provides examples of the risk assessment strategy and tools linking process to attributes, the use of prior platform knowledge and experimental design for mammalian cell culture development, the concept of an engineering design space for the bioreactors, and potential implications for validation and lifecycle.

Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Bioproduct R&D, Eli Lilly and Company

Downstream Process Development Using a QbD Approach - Results from the CMC Biotech Working Group Case Study
The QbD approach for the downstream development of a monoclonal antibody as described in the recent industry consortium case study (CMC BWG) will be presented. This presentation will focus on risk assessments, DOEs and process characterization studies that provide a science-based approach to process understanding, definition of design space and establishment of the control strategy.

Amit Banerjee, Ph.D., Research Fellow, Global Biologics, Pfizer Inc.

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